Study of BXCL501 In Agitation Associated With Delirium in ICU Patients

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Agitation, Delirium

In brief

This study is designed to determine and evaluate the optimal BXCL501 starting dose (StartD) that will safely and effectively reduce agitation associated with delirium in ICU patients. This is an ascending adaptive dose study evaluating the safety and efficacy of four potential starting doses of BXCL501 (120 μg, 180 μg, 240 μg, and 300 μg) in reducing agitation levels in adult ICU patients with delirium. For subjects 65 years of age and older, the potential doses will be reduced 50% in line with the Precedex (reference drug) label. The purpose of this clinical trial is to identify an optimally safe and effective BXCL501

Key facts

Study ID

NCT05313386

Run by

BioXcel Therapeutics Inc

People needed

0

Starts

2021-02-23

Expected to finish

2022-02-21

Last updated by the study team

2022-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria for Enrollment (Informed Consent):
• ICU admitted male and female patients, ≥ 18 years, COVID 19 (+) and (-)
• Subject or legally appointed representative (LAR) able to read, understand and provide informed consent, or to provide assent
• Inclusion Criteria for Randomization:
• Positive CAM-ICU
• RASS score ≥ +1
• Subject judged to be likely capable of self-administration

You may not qualify if…

• Clinically significant ECG changes, brady- and tachyarrhythmias, QTc prolongation
• Hepatic dysfunction
• Pregnancy
• Known allergy to Dexmedetomidine or Haloperidol.

Where it is running

• BioXcel Clinical Research Site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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